Suturing device, in particular for suturing lacerations of the meniscus

ABSTRACT

A suturing device, in particular for suturing lacerations of the meniscus, comprising: a needle provided with a longitudinal cavity extending along a main direction; at least a first and a second member slidably inserted in the cavity and arranged in succession along the main direction; a surgical thread slidably inserted in the cavity and connected to the first and second member, wherein the the first and second member each comprise at least one pair of bodies connected together by means of a junction. Other aspects may be disclosed and claimed.

The present invention relates to a suturing device, in particular forsuturing lacerations of the meniscus.

Therefore, the present invention finds particular application in themedical and biomedical fields, especially in the designing andmanufacturing of instruments for arthroscopic surgery.

In fact, one of the most common operations at the orthopaedic level isrepairing lacerations of the meniscus, in particular lacerationsoccurring on the sides of the meniscus and that need to be sutured indue time in order to prevent them from deepening and thus portions ofthe meniscus from detaching.

In prior art instruments for repairing the lacerations of the meniscusby using arthroscopy are known, some of which allow to suture suchlacerations in a short time and with extreme precision.

One of the best-known systems to perform these operations is marketed bySmith & Nephew® and involves the use of a grooved needle slidablyinserted into a cannula and to which a surgical thread and two membersor retainer bodies are associated.

In particular, the first and the second members are defined by therespective metal plates arranged in succession along the needle andslidably connected to it; both these plates are associated to thesurgical thread.

Operationally, the surgeon inserts the cannula into the patient's kneewith a predetermined angle and, by means of suitable manoeuvring means,moves the needle in order to pierce the meniscus in two places situatedon two opposite points of the laceration (transversally orlongitudinally).

Following each perforation, one of the above members is released (it isdone always by using manoeuvring means) on the outside of the meniscusso that it defines an abutment that allows to tension the surgicalthread along the laceration, thus suturing it.

For this reason, the surgical thread comprises at least a looped andknotted portion with a kind of slip knot between the two members, sothat after placing both members on the external side of the meniscus,the pull of the free end of the thread creates a “pulley” effect on saidring-shaped portion thus allowing to occlude the laceration by pullingtogether its flaps.

Note that the plates have a substantially rectangular shape and areedgewise housed in the needle (and in the cannula), so that their lyingplane is parallel to the development direction of the cannula.

Therefore, the “short” side of each plate has a suitable size to behoused inside the sheath and the “long” side is long enough todistribute the effort on the meniscus without applying overpressurepoints close to the laceration.

Therefore, following the release, such plates tend to rotate on thesurface so that their flat surface abuts on the meniscus.

Disadvantageously, this solution has some drawbacks, related to both theplates structure and the arrangement of the thread.

First, the planar shape of the plates results in the occurrence of highstress along their perimeter, and thus additional lacerations of themeniscus may occur.

Furthermore, the possibility that the plate can be abutted on themeniscus in a non perfectly planar configuration, although unlikely,makes it delicate to assemble the device.

Moreover, the need to linearly move the plates substantially obliges themanufacturer to use a grooved needle that acts as a guide/rail for theplate itself, and the cannula must be compulsorily inserted in order tomaintain the members and the thread isolated from the externalenvironment.

Moreover, the fact that the needle occupies most of the space within thecannula, thus making it unusable for any other purpose, greatly limitsthe thread diameter that can be used, which is typically no greater than2-0 on the USP scale.

Disadvantageously, the use of such a thin surgical thread increases theconcentration of efforts and as a result it is likely to cause a cuttingeffect when pulling.

This is especially true if the “pulley effect” is taken intoconsideration, which occurs after the thread is pulled because of thepresence of the loop and the “slip” knot, where many portions of thelength of the thread run along the tissues and might damage them.

A further device for suturing of lacerations of the meniscus is knownfrom the publication AU2015202757, in which the members are defined bythe surgical thread, in particular by stretches of the thread that havebeen knotted so that, as a result of pulling, a ball of thread iscreated and is able to define an abutment.

This solution, although theoretically interesting, has the disadvantageof complicating the realization of the device and making it difficult tomanoeuvre it, since pulling or pushing movements at imprecise momentsmight lead to the compaction or the wrong knotting of the thread.

The object of the present invention is therefore to provide a suturingdevice, in particular for suturing lacerations of the meniscus, that isable to overcome the above mentioned drawbacks of the prior art.

In particular, the object of the present invention is to provide a highperforming and easy to realise suturing device.

Moreover, the further object of the present invention is to provide areliable and safe suturing device.

Said objects are reached by a suturing device, in particular forsuturing lacerations of the meniscus, having the characteristics of oneor more of the subsequent claims, in particular comprising a needleprovided with a longitudinal cavity, at least a first and a secondmember slidably inserted in said cavity and arranged in succession and asurgical thread slidably inserted in said cavity and connected to saidfirst and second member.

According to a first aspect of the present invention, the first and thesecond members each comprise at least a pair of bodies connectedtogether by means of a junction element.

Preferably, these bodies are substantially spheres or substantiallyspherical bodies.

Therefore, each member includes a pair of spheres connected one to theother by means of a junction element.

Advantageously, in this way each pair of spheres, upon releasing, abutson the external side of the meniscus, it defines an abutment but limitsthe maximum efforts.

Moreover, preferably, each sphere has a diameter that substantiallycorresponds to an inner diameter of the cavity.

Therefore, advantageously, the use of the spheres allows to minimize theneedle size and maximize the size of the members.

In this respect, it should be noted in fact that the first and thesecond members (i.e. all spheres) are entirely contained in the needlecavity; in particular, each pair of spheres comprises a first and asecond sphere arranged one next to the other along said cavity.

Furthermore, the thread too is positioned in the needle, at least in theportion associated to the members, thus making the presence of thecontainment cannula superfluous and allowing the realization of a moreessential device with minimization of its size.

Preferably, to allow a better grip, the junction element between thebodies (i.e. the spheres) of each member is flexible.

A further aspect of the present invention resides in the connectionbetween the surgical thread and the members that, as described above,was often a delicate aspect in the prior art upon pulling/suturing.

According to this (optional and stand-alone) aspect of the invention, infact the surgical thread is slidably associated to said second member sothat, following the pulling by the surgeon, the thread portioninterposed between the two members shortens, thus suturing thelaceration.

Preferably, the surgical thread is constrained to the member incorrespondence to the respective junction element by means of a knot orwrapping in which the thread is maintained sliding.

Therefore, the knot or wrapping stays in correspondence to the secondmember and it remains there even after the pulling, whereas the surgicalthread linearly develops between the two members without further knottedportions.

Advantageously, the knot or wrapping remains so positioned on the secondmember also as a result of pulling on the part of the surgeon, thuseliminating the risk of damage to the tissues that occur in the priorart and are due to the movement or sliding of the knot.

Note that, in an alternative application, a device according to thepresent invention may find application using the members as boneanchors.

Advantageously, in fact, by depositing the two bodies in successioninside the bone cavity (realized by means of a suitable tool/millingcutter) and then by pulling, the overall size of the two bodies (i.e.the two spheres) prevents them from sliding out of the cavity andguarantees the endurance of the suture.

These characteristics and the corresponding technical advantages willbecome more apparent from the following exemplary, and thereforenon-limiting description of a preferred, and therefore not exclusive,embodiment of a suturing device, in particular for the suturing oflacerations of the meniscus, as described in the attached drawings,where:

FIG. 1 shows a schematic view of a suturing device, in particular forthe suturing of lacerations of the meniscus according to the presentinvention;

FIG. 2 shows a schematic cross-sectional view of part of the device ofFIG. 1;

FIG. 3 shows a perspective view of a suturing device, in particular forthe suturing of lacerations of the meniscus that is being used;

FIGS. 4a-4d show a schematic sequence of surgical steps performed byusing the suturing device of FIG. 3;

FIG. 5 shows a special suturing device, in particular for the suturingof lacerations of the meniscus according to the present invention;

FIG. 6 schematically shows a suturing device according to the presentinvention in an alternative application.

With reference to the appended figures, number 1 indicates a suturingdevice, in particular for suturing lacerations of the meniscus,according to the present invention.

Device 1 is therefore mainly used in the orthopaedic sector, preferablywhen arthroscopic surgery or semi-open technique are used for repairingthe meniscus.

Such a device therefore comprises at least one needle 2 extending alongits own main direction “A” and provided with a longitudinal cavity 3.

The needle 2 has a first operational and pointed end portion 2 a, and asecond end portion 2 b, preferably connected to the handle of the device1. Note that the first end portion 2 a may have a rectilinearorientation, aligned with the remaining part of the needle, or a curvedorientation, with a variable angle according to the needs of the surgeonand lacerated area that needs suturing.

Preferably, the needle 2 is a substantially tubular body and thelongitudinal cavity 3 is of the through type, which also extends alongthe main direction “A” between a first opening located at the first endportion 2 a and a second opening located at the second end portion 2 b.

Therefore, the cavity 3 is a duct laterally occluded by the needle walland accessible from the openings.

A first 4 and a second 5 member, as well as a surgical thread 6 arehoused (or can be housed) Inside the needle 2, in particular inside thecavity.

The members 4, 5 are shaped bodies to define an abutment to abut theouter wall of the meniscus during the pulling of the thread.

Preferably, these first 4 and second 5 members are slidably insertedinto the longitudinal cavity 3 of the needle 2.

More preferably, the first 4 and second 5 members are completelycontained in the cavity 3 of the needle 2.

Moreover, such members 4, 5 are arranged in succession along the maindirection “A”.

Such members 4, 5 are also mutually connected through the surgicalthread 6, which is also slidably inserted into the cavity 3 (as it willbe better explained hereinafter).

According to one aspect of the present invention, the first 4 and thesecond 5 members each comprise at least a pair of bodies 7, 8, 10, 11connected together by means of a junction element 9, 12.

Preferably, the bodies are each defined by a sphere 7, 8, 10, 11 or asubstantially spherical body.

Note that, in the spirit of the present invention, by using the term“sphere” what is not intended is restricting the conformation of theelements constituting the members to perfectly spherical bodies, butthose “substantially spherical” elements, having an oval or ovoid shape,are also encompassed, since they may as well meet the specifications ofthe present invention.

In other words, in its most generic sense, the term sphere is used hereto simply define a “rounded, preferably spherical body”.

Therefore, the first member 4 comprises a first 7 and a second 8 sphere(or first and second body) that are connected one to the other by meansof a special junction element 9.

In the same way, the second member 5 comprises a first 10 and a second11 sphere (or first and second body) that are connected one to the otherby means of a special junction element 12.

Preferably, such spheres 7, 8, 10, 11 have a diameter (or moregenerically a transverse size) substantially corresponding to an insidediameter of the cavity 3.

In other words, the spheres 7, 8, 10, 11 are substantially shaped forthe cavity 3.

Therefore, these spheres 7, 8, 10, 11 are substantially inserted to fitin the cavity 3.

In the preferred embodiment of the invention, the spheres (or bodies) 7,8, 10, 11 are made of polymeric material, more preferably ofPoly-Ether-Ether-Ketone (PEEK) or Poly-L-lactide-co-D, L-lactide(PLDLLA).

The junction element 9, 12 is a bridge that connects the two spheres 7,8, 10, 11 (or the two bodies) of each member 4, 5.

In certain embodiments, such a junction element 9, 12 is flexible toallow a relative movement between said spheres (or bodies) 7, 8, 10, 11of each member 4, 5.

For example, such a junction element 9, 12 can be made of a portion ofsurgical thread, preferably a multi-filament suturing thread.

Alternatively, in an embodiment that is not illustrated, the junctionelement comprises a rigid pin extending between two ends each secured toa respective sphere.

In this embodiment, the junction element acts as a spacer between thetwo spheres of the individual member.

Preferably, the surgical thread 6 is slidably associated to said secondmember 5, more preferably (but not necessarily) to the junction element12 of the member.

In the preferred embodiment, in fact, the surgical thread 6 isassociated to said second member 5 in correspondence of the respectivejunction element 12 by means of a knot or wrapping in which the thread 6is maintained sliding.

Therefore, the thread 6 is slidably constrained to the junction element12 so as to slide along the thread by varying the length of the threadportion 6 a interposed between the first 4 and the second 5 member, thusallowing the laceration to be sutured.

In other words, the thread defines the knot or wrapping that remainssubstantially in position on the second member 5 (or on the junctionelement 12), but it is slidable in such a way that the thread portion 6defining the knot or the wrapping, changes upon pulling by the surgeon.

Therefore, the knot or wrapping does not move, whereas the thread 6 thatdefines it, is slidable.

In the preferred embodiment, this sliding knot or wrapping is a doublethread point or the likes.

Advantageously, in such a way the knot does not move along the tissues,but the thread 6 only moves linearly, which greatly reduces friction andthe wear action of the thread.

Therefore, the surgical thread 6 extends between a first end portion 6 aconstrained to the first member 4, and a second end portion 6 b, in useexternally projecting to an end opposite the needle tip 2, or externallyprojecting to the second end portion 2 b.

More in detail, the thread 6 comprises a first suturing portion 13,interposed between the first 4 and the second 5 member having a variablelength, and a second pulling portion 14, which develops between thesecond member 5 and the second end portion 6 b.

Preferably, the second end portion 6 b can be held by the surgeon topull the thread 6 b, thus allowing the sliding thereof with respect tothe second member 5 and reducing the length of the first portion 13 forsuturing the laceration.

Note that the first portion, the junction between the two members 4, 5,has a substantially linear development, i.e. without the presence ofknots or wrapping between the two members 4, 5.

In fact, the only functional knot or wrapping in the thread 6 is locatedat the second member 5, in particular at the junction element 12.

With the expression “functional knot or wrapping”, what is meant is theknot or wrapping that is able to perform an additional function otherthan the function of keeping together the two elements, e.g. allowingthe sliding of an element (thread 6) in relation to the other element(junction element 12).

In the illustrated embodiment, in fact, the thread also has a fixingknot at its first end portion 6 a to immovably constrain the same thread6 to the junction portion 9 of the first member 4.

Note that the at least second sphere 8 of the first member 4 and spheres10, 11, of the second member 5 have a peripheral groove 15 for housingthe surgical thread 6 so as to minimize the size of the needle 2.

In particular, the grooves 15 extend along the main direction “A” of theneedle 2 and are accessible peripherally so as to house the thread 6when the members are inside the needle 2, thus allowing its releaseafter sliding out. Preferably, all the spheres are equipped with such agroove 15.

Advantageously, in such a way it is possible to simultaneously minimizethe size of the needle 2 (or the cavity 3) and maximize the size of thesurgical thread 6 (which can substantially reach the value for thesphere radius).

Preferably, in fact, the surgical thread 6 presents a gauge between 2-0and 0 on the USP scale, or preferably equal to 0 on the USP scale (about0.350-0.399 mm).

Associated to the second end portion 2 b of the needle 2, what isenvisaged are movement means 16 of the first 4 and second 5 memberconfigured to translate each member 4, 5 from a rest position, in whichit is housed inside the cavity 3 of the needle 2 to an operatingposition, in which it is proximal to or externally projecting from thetip of the needle 2.

Therefore, the movement means 16 comprise at least one distal actuatingmember 16 a from the tip (or from the first end portion 2 a) of saidneedle 2 and operable by a user.

Therefore, the movement means 16 are projecting from the second endportion 2 b of the needle 2 and comprise both a handle 16 b and saidactuating member 16 a.

Preferably, the actuating member comprises at least a pusher element(not shown) slidably inserted into the needle 2 (or in the cavity) toget hold of the members 4, 5 and drive them from the rest position tothe operating position.

Moreover, such actuating member is also provided with a control portion,proximal to the handle, that can be used by a user (i.e. the surgeon)for manoeuvring the pusher element.

Note that the pusher element is movable in at least threeconfigurations, namely a first configuration in which both members arein the rest position, a second configuration in which the first memberis in the operating position and the second member is in the restposition (or in an intermediate position between the two) and a thirdconfiguration in which both members are in the operating position.

With reference to FIG. 6 an alternative application of the device 1′ isshown according to the present invention.

In this application, the member 4′ is used as a bone anchor, for examplefor attaching tissues such as tendons.

Operationally, the procedure or graft procedure is comparable to whathas been described up to now, the only difference is related to the needto preliminarily drill the bone cortical tissue “CB” giving access tothe organic component “SB” of the bone, i.e. the soft bone tissue.

More precisely, in this embodiment the method envisages to drill a holein the bone by means of a tool able to realize an undercut “UC” betweenthe cortical tissue “CB” and the bone organic component “SB”.

Therefore, downstream of the drilling, the cortical tissue “CB” has athrough hole “H1” of diameter d1, whereas the bone organic component“SB” has a cavity “H2” substantially concentric to the hole “H1” andhaving a diameter d2 greater than diameter d1.

Alternatively, a similar procedure may provide for the drilling of athrough-hole in the bone such as to have just one through-hole “H1” ofdiameter d1; in such an alternative the member 4′ is not placed insidethe bone cavity, but outside it, so as to define, for example, an anchorfor the new fixing of the bone in the event of fracture.

Therefore, in the present embodiment, the device is inserted in the hole“H1” so as to pass completely through the bone (anchor for the newfixing of the bone) or for access to the cavity “H2” (anchor for tissuefixation), without substantial modifications in the operating principleand in the structure of the device.

For this reason, explicit reference will be hereinafter made to just oneembodiment illustrated in FIG. 6 (tissue fixation), in which after thedrilling of the bone the device 1′, the needle in particular, isinserted into the cavity “H2”.

Note that in this application, given the absence of a direct drilling bythe device 1′, the needle can be equivalently replaced by a tubular (orsemi-tubular) body devoid of a tapered portion, whose only purpose isallowing the sliding of members on the inside.

Structurally, moreover, this embodiment of the device 1′ may comprise asingle member 4′ (formed by two bodies 7′, 8′) insertable into thecavity “H2”.

Preferably, the single member 4′ is formed by at least two bodies 7 and8′ connected to one another by a junction element 9′.

The suturing thread 6′ is fixed to said junction element 9′, preferablyin a middle portion of said element.

In this manner, after inserting the two bodies 7′, 8′ one after theother in the cavity “H2” through the tubular body, upon pulling thesuturing thread 6′ toward the outside of the same cavity “H2” thecorresponding rotation of the two bodies 7′, 8′ in the cavity “H2”occurs, so that they are placed one next to the other and they cannotpass through the hole “H1”.

In this regard, in fact, the two bodies 7′, 8′ each have a transversesize shorter than the hole diameter “H1” so that they can enter thecavity “H2”, but which, after being added to the size of the other body,is longer than the diameter of the hole “H1”, so as to be able to definethe fixing anchor that is used by the surgeon, for example, to connect atendon to the bone.

Preferably, and in accordance with what has been described, the twobodies 7′, 8′ are spheres.

The junction element 9′ is preferably a flexible/elastic body thatallows a simple rotation and does not hinder insertion.

Preferably, each body 7′, 8′ has a through hole within which an end ofthe junction element 9′ is inserted.

More preferably, the junction element 9′ has enlarged portions at itsends, so as to interfere with the edges of the corresponding throughhole, thus preventing the body 7′, 8′ from sliding.

In the preferred embodiment, the junction element develops substantiallyinto the “V” shape, i.e. it has two angled portions extending betweentwo free ends and a common vertex.

In particular, the two free “V” ends are each connected to a respectivebody 7′, 8′.

Preferably, the vertex is connected to the suturing thread 6′.

In the preferred embodiment, the suturing thread 6′ and the junctionelement 9′ are made in one piece. This allows to guarantee the correctpositioning of the thread 6′ with respect to the junction element 9′ andtherefore to facilitate rotation inside the cavity “H2”.

Alternatively, however, the thread 6′ may be knotted or secured (alsoslidably) to the junction element 9′ in some other way.

Structurally, therefore, the device 1′ according to the presentinvention used as a bone anchor could be simplified (no needle andmember reduction), without thereby deviating from what is the spirit ofthe present invention, of which, therefore, such application is fullypart.

In this respect, therefore, everything that has been previouslydescribed in relation to the suturing device for suturing lacerations ofthe meniscus and compatible with the application of the herein discussedbone anchor is also applicable, both structurally and procedurally.

The invention achieves the intended objects and provides importantadvantages.

In fact, the use of members comprising (at least in part) pairs ofspheres connected together by means of junction elements allows on theone hand to minimize the efforts on the tissues after suturing thelaceration and on the other hand to minimize the size of the needle.

Moreover, by being able to fully insert both the members and the threadinside the needle (a tubular and not grooved needle) there is no need toprovide the device with a containment tube, thus making it a morecompact and simple device.

Furthermore, by providing the spheres with an adequate groove what ispossible is increasing the size of the surgical thread up tosubstantially the size of the radius of each sphere, thus allowing toreach even the gauge=or the upper gauge.

Again, the absence of knots between the two members and the substantialabsence of annular wrappings between the knot and the second membermakes less critical and less invasive the pulling phase and suturing ofthe laceration, as the friction of the thread on the tissues is greatlyreduced.

1.-14. (canceled)
 15. A suturing device, in particular for suturinglacerations of the meniscus, comprising: a needle provided with alongitudinal cavity extending along a main direction; at least a firstand a second member slidably inserted in the cavity and arranged insuccession along the main direction; a surgical thread slidably insertedin the cavity and connected to the first and second member, wherein thethe first and second member each comprise at least one pair of bodiesconnected together by means of a junction.
 16. The suturing deviceaccording to claim 15, wherein the bodies of the first and second memberare spheres connected between them by means of a junction element. 17.The suturing device according to claim 16, wherein the the needle istubular and the cavity is of the through type; each of the spheres ofeach member has a diameter corresponding to an inner diameter of thecavity.
 18. The suturing device according claim 15, wherein the firstand second member are entirely contained in the cavity of the needle.19. The suturing device according to claim 15, wherein each pair of thebodies comprises a first and a second sphere arranged in successionalong the cavity.
 20. The suturing device according to claim 19, whereinat least the second sphere of the first member and the spheres of thesecond member have a peripheral groove for housing the surgical threadso as to minimize the size of the needle.
 21. The suturing deviceaccording to claim 15, wherein the junction element between the bodiesof each member is flexible.
 22. The suturing device according to claim15, wherein the the surgical thread is slidably associated to the secondmember.
 23. The suturing device according to claim 20, wherein thesurgical thread is constrained to the second member in correspondence ofthe respective junction element by means of a knot or wrapping in whichthe thread is maintained sliding.
 24. The suturing device according toclaim 15, wherein the thread extends between a first and a second endportion and comprises: a first suture portion, extending from the firstend portion to a position located between the first and the secondmember, and a second pulling portion, which develops between the secondmember and the second end portion; wherein both portions are of variablelength according to a pulling action performed on the second endportion.
 25. The suturing device according to claim 24, wherein thefirst portion of the thread has a linear, knot-free development or has asingle knot for fastening on the junction element of the first member.26. The suturing device according to claim 15, wherein the suturingdevice comprises movement means for the first and second memberconfigured to translate each member from a rest position, in which it ishoused inside the cavity of the needle, to an operating position, inwhich it is proximal to or externally projecting from a tip of theneedle.
 27. The suturing device according to claim 24, wherein the themovement means comprise at least one actuating member distal from a tipof the needle and operable by a user.
 28. The suturing device accordingto claim 15, wherein the the surgical thread has a gauge of 0 accordingto the USP scale.